This medical device record is a pma supplement. A supplement may have changed the device description/function or indication from that approved in the original pma. Be sure to look at the original pma record for more information.
Approval for the addition of model 4067, 4568, 5067, 5068 and 5568 to the capsurefix(r) line. These lead models will also be distributed by viatron, inc. , under the tradename "pirout" (models imu49, imu49jb, imx49, imx49b and imu49jb).
| Device | MEDTRONIC(R) CAPSUREFIX MODEL 4067/4568/5067/5068/5568 PACING LEAD |
| Classification Name | Permanent Pacemaker Electrode |
| Generic Name | Permanent Pacemaker Electrode |
| Applicant | Medtronic, Inc. |
| Date Received | 1996-06-24 |
| Decision Date | 1997-01-02 |
| PMA | P930039 |
| Supplement | S002 |
| Product Code | DTB |
| Advisory Committee | Cardiovascular |
| Supplement Type | Normal 180 Day Track |
| Supplement Reason | Location Change - Manufacturer/sterilizer/packager/supplier |
| Expedited Review | No |
| Combination Product | No |
| Applicant Address | Medtronic, Inc. 8200 Coral Sea Street N.e. mounds View, MN 55112 |
| Supplement Number | Date | Supplement Type |
|---|---|---|
| P930039 | Original Filing | |
| S248 | 2023-01-09 | 30-day Notice |
| S247 | 2022-11-16 | 30-day Notice |
| S246 | 2022-10-19 | 30-day Notice |
| S245 | 2022-09-13 | 30-day Notice |
| S244 | 2022-06-17 | Normal 180 Day Track No User Fee |
| S243 | 2022-05-20 | 30-day Notice |
| S242 | 2022-05-10 | 30-day Notice |
| S241 | 2022-04-14 | 30-day Notice |
| S240 | 2022-03-21 | 30-day Notice |
| S239 | 2022-02-23 | 30-day Notice |
| S238 | ||
| S237 | 2022-01-28 | 30-day Notice |
| S236 | 2022-01-13 | 30-day Notice |
| S235 | 2021-11-19 | 30-day Notice |
| S234 | ||
| S233 | ||
| S232 | 2021-09-24 | 30-day Notice |
| S231 | 2021-09-23 | 30-day Notice |
| S230 | 2021-08-20 | 30-day Notice |
| S229 | 2021-08-09 | 30-day Notice |
| S228 | 2021-06-15 | 30-day Notice |
| S227 | 2021-05-03 | 30-day Notice |
| S226 | 2021-04-28 | 30-day Notice |
| S225 | 2021-04-20 | 30-day Notice |
| S224 | 2021-03-19 | 30-day Notice |
| S223 | 2021-02-05 | 30-day Notice |
| S222 | 2020-12-08 | 30-day Notice |
| S221 | 2020-12-07 | 30-day Notice |
| S220 | ||
| S219 | 2020-12-01 | 30-day Notice |
| S218 | ||
| S217 | 2020-10-23 | 30-day Notice |
| S216 | 2020-10-15 | 30-day Notice |
| S215 | 2020-09-17 | 30-day Notice |
| S214 | 2020-07-09 | 30-day Notice |
| S213 | 2020-07-08 | 30-day Notice |
| S212 | ||
| S211 | 2020-03-23 | Real-time Process |
| S210 | 2020-02-20 | 30-day Notice |
| S209 | 2020-01-31 | 30-day Notice |
| S208 | 2019-11-18 | 30-day Notice |
| S207 | 2019-11-18 | 30-day Notice |
| S206 | ||
| S205 | 2019-11-12 | 30-day Notice |
| S204 | 2019-09-11 | 30-day Notice |
| S203 | 2019-07-01 | 30-day Notice |
| S202 | ||
| S201 | 2019-06-20 | 30-day Notice |
| S200 | 2019-06-18 | 30-day Notice |
| S199 | 2019-06-10 | 30-day Notice |
| S198 | 2019-05-29 | 30-day Notice |
| S197 | 2019-05-02 | Normal 180 Day Track No User Fee |
| S196 | 2019-02-28 | 30-day Notice |
| S195 | 2018-11-21 | 30-day Notice |
| S194 | ||
| S193 | 2018-10-23 | 30-day Notice |
| S192 | 2018-10-18 | 30-day Notice |
| S191 | 2018-09-26 | 30-day Notice |
| S190 | 2018-06-20 | 30-day Notice |
| S189 | 2018-06-01 | 30-day Notice |
| S188 | 2018-05-15 | 30-day Notice |
| S187 | 2018-05-11 | 30-day Notice |
| S186 | 2018-04-13 | Normal 180 Day Track |
| S185 | 2018-04-09 | 30-day Notice |
| S184 | 2018-04-06 | 30-day Notice |
| S183 | 2018-03-28 | 30-day Notice |
| S182 | 2018-03-16 | 30-day Notice |
| S181 | 2018-03-06 | 30-day Notice |
| S180 | 2018-02-22 | 30-day Notice |
| S179 | 2017-12-04 | Real-time Process |
| S178 | 2017-11-20 | 30-day Notice |
| S177 | 2017-10-20 | 30-day Notice |
| S176 | 2017-10-13 | 30-day Notice |
| S175 | 2017-08-07 | 30-day Notice |
| S174 | 2017-06-28 | 30-day Notice |
| S173 | 2017-06-23 | 30-day Notice |
| S172 | 2017-06-07 | 30-day Notice |
| S171 | 2017-06-02 | 30-day Notice |
| S170 | 2017-05-18 | Normal 180 Day Track |
| S169 | 2017-04-03 | Normal 180 Day Track |
| S168 | 2017-01-25 | Real-time Process |
| S167 | 2017-01-24 | 30-day Notice |
| S166 | 2016-12-06 | Normal 180 Day Track |
| S165 | 2016-12-06 | Normal 180 Day Track |
| S164 | 2016-11-28 | 30-day Notice |
| S163 | 2016-11-14 | 30-day Notice |
| S162 | 2016-11-02 | Normal 180 Day Track |
| S161 | 2016-10-05 | 30-day Notice |
| S160 | 2016-09-23 | 30-day Notice |
| S159 | 2016-09-12 | 30-day Notice |
| S158 | 2016-09-02 | 30-day Notice |
| S157 | 2016-08-29 | 30-day Notice |
| S156 | 2016-08-25 | 30-day Notice |
| S155 | 2016-08-02 | 30-day Notice |
| S154 | 2016-07-26 | 30-day Notice |
| S153 | 2016-06-24 | 30-day Notice |
| S152 | 2016-05-03 | Normal 180 Day Track |
| S151 | 2016-04-15 | Normal 180 Day Track |
| S150 | 2016-03-23 | 30-day Notice |
| S149 | 2016-03-11 | Normal 180 Day Track |
| S148 | 2016-03-01 | Normal 180 Day Track |
| S147 | 2015-12-28 | 30-day Notice |
| S146 | 2015-12-28 | 30-day Notice |
| S145 | 2015-12-22 | 30-day Notice |
| S144 | 2015-12-04 | 30-day Notice |
| S143 | 2015-10-23 | 30-day Notice |
| S142 | 2015-10-13 | Normal 180 Day Track |
| S141 | 2015-09-30 | 30-day Notice |
| S140 | 2015-09-24 | Normal 180 Day Track |
| S139 | 2015-09-17 | 30-day Notice |
| S138 | 2015-03-16 | Normal 180 Day Track |
| S137 | 2015-09-10 | 30-day Notice |
| S136 | 2015-07-20 | 30-day Notice |
| S135 | 2015-07-01 | 30-day Notice |
| S134 | 2015-06-19 | 30-day Notice |
| S133 | 2015-06-18 | 30-day Notice |
| S132 | 2015-05-18 | 30-day Notice |
| S131 | 2015-05-18 | 30-day Notice |
| S130 | 2015-04-20 | Normal 180 Day Track |
| S129 | 2015-04-17 | 30-day Notice |
| S128 | 2015-04-16 | 30-day Notice |
| S127 | 2015-03-26 | 30-day Notice |
| S126 | 2015-02-26 | 30-day Notice |
| S125 | 2015-02-09 | 30-day Notice |
| S124 | 2015-01-21 | 30-day Notice |
| S123 | 2014-12-08 | Normal 180 Day Track |
| S122 | 2014-12-08 | 30-day Notice |
| S121 | 2014-09-29 | 30-day Notice |
| S120 | 2014-09-26 | 30-day Notice |
| S119 | 2014-09-15 | 30-day Notice |
| S118 | 2014-08-27 | 30-day Notice |
| S117 | 2014-08-27 | 30-day Notice |
| S116 | 2014-08-12 | 30-day Notice |
| S115 | 2014-08-08 | 30-day Notice |
| S114 | 2014-07-28 | 30-day Notice |
| S113 | 2014-07-24 | 30-day Notice |
| S112 | 2014-07-11 | 30-day Notice |
| S111 | 2014-06-19 | 30-day Notice |
| S110 | 2014-06-16 | 30-day Notice |
| S109 | 2014-05-22 | 30-day Notice |
| S108 | 2014-05-12 | 30-day Notice |
| S107 | 2014-04-17 | Normal 180 Day Track |
| S106 | 2014-03-07 | 30-day Notice |
| S105 | 2014-02-27 | 30-day Notice |
| S104 | 2014-01-29 | 30-day Notice |
| S103 | 2014-01-22 | 30-day Notice |
| S102 | 2013-12-24 | 30-day Notice |
| S101 | 2013-12-19 | 30-day Notice |
| S100 | 2013-12-17 | 30-day Notice |
| S099 | ||
| S098 | 2013-12-12 | 30-day Notice |
| S097 | 2013-11-27 | 30-day Notice |
| S096 | 2013-10-30 | 30-day Notice |
| S095 | 2013-10-24 | 30-day Notice |
| S094 | 2013-09-30 | 30-day Notice |
| S093 | 2013-09-17 | 30-day Notice |
| S092 | 2013-06-07 | 30-day Notice |
| S091 | ||
| S090 | 2013-05-21 | 30-day Notice |
| S089 | 2013-05-17 | Real-time Process |
| S088 | 2013-04-30 | 30-day Notice |
| S087 | 2013-04-25 | 30-day Notice |
| S086 | ||
| S085 | 2013-04-09 | Normal 180 Day Track No User Fee |
| S084 | 2013-03-22 | 30-day Notice |
| S083 | 2013-03-20 | 30-day Notice |
| S082 | 2013-01-14 | 30-day Notice |
| S081 | 2012-12-17 | 30-day Notice |
| S080 | 2012-12-10 | 30-day Notice |
| S079 | 2012-11-29 | 30-day Notice |
| S078 | 2012-11-21 | 30-day Notice |
| S077 | 2012-11-01 | 30-day Notice |
| S076 | 2012-10-22 | 30-day Notice |
| S075 | 2012-09-28 | 30-day Notice |
| S074 | 2012-09-21 | 30-day Notice |
| S073 | 2012-09-04 | 30-day Notice |
| S072 | 2012-08-31 | Normal 180 Day Track No User Fee |
| S071 | 2012-08-03 | 30-day Notice |
| S070 | 2012-07-18 | 30-day Notice |
| S069 | 2012-07-13 | 30-day Notice |
| S068 | 2012-06-11 | 30-day Notice |
| S067 | 2012-03-09 | 30-day Notice |
| S066 | 2012-02-29 | 30-day Notice |
| S065 | 2011-11-25 | 30-day Notice |
| S064 | 2011-11-21 | Normal 180 Day Track |
| S063 | 2011-10-24 | 135 Review Track For 30-day Notice |
| S062 | 2011-08-12 | 30-day Notice |
| S061 | 2011-07-18 | 30-day Notice |
| S060 | 2011-07-08 | 30-day Notice |
| S059 | 2011-06-28 | 30-day Notice |
| S058 | 2011-06-27 | 30-day Notice |
| S057 | 2011-06-08 | 30-day Notice |
| S056 | 2011-06-08 | 135 Review Track For 30-day Notice |
| S055 | 2011-06-01 | 30-day Notice |
| S054 | ||
| S053 | 2011-05-13 | 30-day Notice |
| S052 | 2011-04-26 | 30-day Notice |
| S051 | 2011-04-22 | 30-day Notice |
| S050 | 2011-03-22 | 135 Review Track For 30-day Notice |
| S049 | 2011-03-18 | 135 Review Track For 30-day Notice |
| S048 | 2011-02-28 | 30-day Notice |
| S047 | 2010-11-12 | 30-day Notice |
| S046 | 2010-10-26 | 30-day Notice |
| S045 | 2010-09-29 | 30-day Notice |
| S044 | ||
| S043 | 2010-07-28 | 30-day Notice |
| S042 | 2010-07-15 | 30-day Notice |
| S041 | 2010-07-15 | 30-day Notice |
| S040 | 2010-07-15 | 30-day Notice |
| S039 | 2010-06-28 | 135 Review Track For 30-day Notice |
| S038 | ||
| S037 | 2010-04-19 | 30-day Notice |
| S036 | 2010-03-29 | 30-day Notice |
| S035 | 2010-01-19 | 30-day Notice |
| S034 | 2009-10-09 | 30-day Notice |
| S033 | 2009-10-08 | Real-time Process |
| S032 | 2009-04-10 | 30-day Notice |
| S031 | 2009-03-17 | Real-time Process |
| S030 | 2009-02-05 | 30-day Notice |
| S029 | 2008-12-11 | 30-day Notice |
| S028 | ||
| S027 | 2008-04-23 | 135 Review Track For 30-day Notice |
| S026 | 2008-03-24 | 30-day Notice |
| S025 | 2008-03-10 | 135 Review Track For 30-day Notice |
| S024 | 2008-01-04 | 30-day Notice |
| S023 | 2007-06-27 | 30-day Notice |
| S022 | 2007-05-18 | 30-day Notice |
| S021 | ||
| S020 | 2004-09-10 | Normal 180 Day Track |
| S019 | 2004-03-01 | 135 Review Track For 30-day Notice |
| S018 | 2004-02-10 | 30-day Notice |
| S017 | 2003-11-13 | Real-time Process |
| S016 | 2003-07-02 | Real-time Process |
| S015 | 2003-03-04 | 30-day Notice |
| S014 | 2002-12-24 | Real-time Process |
| S013 | 2001-11-14 | Real-time Process |
| S012 | 2001-11-05 | Special (immediate Track) |
| S011 | ||
| S010 | 2001-07-17 | 30-day Notice |
| S009 | 2000-03-13 | Normal 180 Day Track |
| S008 | 2000-01-11 | 30-day Notice |
| S007 | 2000-01-05 | 30-day Notice |
| S006 | 1998-04-20 | |
| S005 | 1998-03-02 | Normal 180 Day Track |
| S004 | 1997-11-17 | Normal 180 Day Track |
| S003 | 1996-11-21 | Normal 180 Day Track |
| S002 | 1996-06-24 | Normal 180 Day Track |
| S001 | 1996-05-02 | Normal 180 Day Track |